Identity
- Trade Name
- Dale IV Line Manager EUDAMEDFDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- Dale IV Line Manager EUDAMEDThe Dale IV Line Manager is a foam device used to separate and organize up to 6 IV Lines FDA UDI
- Model / Reference
- 630 EUDAMEDFDA UDI
- Description
- The Dale IV Line Manager is a foam device used to separate and organize up to 6 IV Lines FDA UDI
Identifiers
- Catalog Number
- 630 FDA UDI
- Primary DI / UDI-DI
- 00817612021107 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612026306L EUDAMED
- FDA Product Code
- PUK FDA UDI
- EMDN Code
- A0580 MECHANICAL INFUSION SYSTEMS, SINGLE-USE - ACCESSORIES EUDAMED
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dale IV Line Manager by Dale Medical Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0817612026306L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
- EUDAMED SRN
- US-MF-000019061
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 27557a6c-a98e-4455-967e-5f5dca0dff6a 61 fields · synced Jun 19, 2026
- FDA UDI 762fb543-7004-4781-b124-9bd2a1de78fe 34 fields · synced May 29, 2026